N/A
- Primary DI
- 00810050240901
- Brand
- N/A
- Company
- DOMICO MED-DEVICE, LLC
- Model
- 9431
- Device description
- 15" DETACHABLE RAIL 9.4MM X 28.5MM
- Published
- 2020-09-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KXJ | Table, Radiologic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KXJ | Table, Radiologic | Radiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810050240901 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810050240901 | 00810050240901 | 810050240901 | 0810050240901 |
GMDN Terms
| Term | Definition |
|---|
| Radiological general body-part positioner | A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. |
Device Sizes
| Type | Value | Unit |
|---|
| Height | 28.5 | Millimeter |
| Length | 15 | Inch |
| Width | 9.4 | Millimeter |
Regulatory Flags
- DUNS number
- 081253414
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00887761973350 | Arm-Positioning | Baxter Medical Systems GmbH + Co. KG | KXJ | 2023-01-05 |
| 00887761967625 | X-Ray-Cassette-Handling | Baxter Medical Systems GmbH + Co. KG | KXJ | 2023-01-03 |
| 00887761967748 | Leg Sections | Baxter Medical Systems GmbH + Co. KG | KXJ | 2023-01-03 |
| 00887761967793 | Head Sections | Baxter Medical Systems GmbH + Co. KG | KXJ | 2023-01-03 |